Azium - Pharmacology:

Azium is a glucocorticoid agonist. Unbound dexamethasone crosses cell membranes and binds with high affinity to specific cytoplasmic receptors. This results in a modification of transcription and, hence, protein synthesis in order to achieve inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, suppression of humoral immune responses, and reduction in edema or scar tissue. The antiinflammatory actions of dexamethasone are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Azium for patients

Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical
supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they
should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once
should they develop an acute illness including fever or other signs of infection. Following prolonged therapy,
withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia,
arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or
measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Azium Interactions

Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered
concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely
for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin
B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in
corticosteroid clearance.

Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may
produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be
withdrawn at least 24 hours before initiating corticosteroid therapy.

Anticoagulants, oral: Co-administration of corticosteroids and warfarin usually results in
inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices
should be monitored frequently to maintain the desired anticoagulant effect.

Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage
adjustments of antidiabetic agents may be required.

Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. Cyclosporine: Increased
activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been
reported with this concurrent use.

Dexamethasone suppression test (DST): False-negative results in the dexamethasone suppression
test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be
interpreted with caution in these patients.

Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias
due to hypokalemia.

Hepatic Enzyme Inducers, Inhibitors and Substrates: Drugs which induce cytochrome P450 3A4
(CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism
of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4
(e.g., ketoconazole, macrolide antibiotics such as erythromycin) have the potential to result in increased
plasma concentrations of corticosteroids. Dexamethasone is a moderate inducer of CYP 3A4. Co-administration with
other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin) may increase their clearance,
resulting in decreased plasma concentration.

Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain
corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole
alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid
withdrawal.

Nonsteroidal anti-inflammatory agents (NSAIDS): Concomitant use of aspirin (or other
nonsteroidal antiinflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects.
Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of
salicylates may be increased with concurrent use of corticosteroids.

Phenytoin: In post-marketing experience, there have been reports of both increases and
decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control.

Skin tests: Corticosteroids may suppress reactions to skin tests.

Thalidomide: Co-administration with thalidomide should be employed cautiously, as toxic
epidermal necrolysis has been reported with concomitant use.

Vaccines: Patients on corticosteroid therapy may exhibit a diminished response to toxoids and
live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the
replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids
should be deferred until corticosteroid therapy is discontinued if possible.

Azium Contraindications

Systemic fungal infections.

DECADRON tablets are contraindicated in patients who are hypersensitive to any components of this
product.